A Phase 2 interventional study of pegaspargase and Gemcitabine in Lymphoma, sponsored by Hunan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by Hunan Cancer Hospital · Phase 2, Interventional, and Treatment
Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study to compare the efficacy of these two regimens. This prospective pilot study to compare the efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for stage IE to IIE ENKTL.
Treatment PA-Gemoxd dosages were as follows: days 1 and 5, 30-min intravenous infusion of 800 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2000 U/m2 PEG-ASP at four different sites; d1-5, intravenous infusion of 15mg dexamethasone. The regimen was repeated every 3 weeks for four cycles followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
Pegaspargase+Gemcitabine+Oxaliplatin+Dexamethasone (PEG-ASP+Gemoxd): Patients received the P-Gemoxd chemotherapy regimen every 3 weeks. Pegaspargase 2000U/m2 im day 1, Gemcitabine 800mg/m2 ivdrip 30min day 1 and day 5, Oxaliplatin 85mg/m2 ivdrip day 1, Dexamethasone 15 mg ivdrip, QD, day 1 to day 5. IMRT：IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.
Drug: pegaspargase · Drug: Gemcitabine · Drug: Oxaliplatin · Drug: Dexamethasone · Radiation: IMRT
Pegaspargase+Cyclophosphamide+Doxorubicin+Vincristine +Prednisone (P-CHOP)：Patients received the P-CHOP chemotherapy regimen every 3 weeks. Cyclophosphamide 750 mg/m2，ivdrip day 1； doxorubicin 50mg/m 2，ivdrip day 1；vincristine 1.4 mg/m 2(≤2mg），ivdrip day 1; Pegaspargase 2000U/m2 im，day 2 and prednisone (60 mg/m 2 /day) on days 1 to 5 orally. IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50-56 grays (Gy) in 25-28 fractions.
Drug: pegaspargase · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone · Radiation: IMRT
P-Gemoxd Arm: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: four. P-CHOP Arm: 2000U/m2 im on day 2 of each 21 day cycle. Number of Cycles: four.
Also known as: Oncaspar
800mg/m2, ivd on day 1 and 5 of each 21 day cycle. Number of Cycles: four.
Also known as: Gemzar
85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four
Also known as: Eloxatin
15 mg, Ivd on day 1 to day 5 of each 21 day cycle. Number of Cycles: four.
750 mg/m2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
50mg/m 2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
1.4 mg/m 2(≤2mg），ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
60 mg/m 2 /day orally on days1- 5 of each 21 day cycle. Number of Cycles: four.
After chemotherapy, if the patients get CR, PR or SD, IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.
Also known as: intensity-modulated radiation treatment
Objective response rate（complete remission rate + partial remission rate）
The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article: Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.
Time frame: every 6 weeks,up to completion of treatment (approximately 6 months)
progression free survival
time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first
Time frame: up to end of follow-up-phase (approximately 3 years)
overall survival
overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first
Time frame: up to end of follow-up-phase (approximately 3 years)
Incidence of Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events v3.0
including hematological safety and non-hematological safety. All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time frame: every 3 weeks,up to completion of treatment (approximately 6 months)
Serum Epstein-Barr virus (EBV) DNA copies
Time frame: every 3 weeks,up to completion of treatment (approximately 6 months)
Plan to share: No
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Hunan Cancer Hospital